Biotechnology major Biocon today said the US health regulator has made seven observations after inspection of its sterile drug product manufacturing facility in Bengaluru this week. The observations are largely procedural and aimed at continuous improvement, Biocon said in a filing to BSE.
The USFDA has completed pre-approval inspection of the sterile drug product manufacturing facility in Bengaluru this week and issued a Form 483 with 7 observations, the filing said.
"We will respond to the USFDA with a corrective and preventive action plan in a timely manner," a Biocon spokesperson said.
The company has also this week received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bengaluru in March 2018, the spokesperson added.
"The report lists 6 major observations with no observation classified as critical. We will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period," the spokesperson said,
An FDA Form 483 is issued to firm management at the conclusion of an inspection by the US FDA. It notifies the company's management of objectionable conditions at the facility.